Braftovi Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Braftovi Capsule contains the active ingredient encorafenib, a kinase inhibitor known as a BRAF inhibitor, which is a type of targeted cancer therapy. It is used to treat certain melanomas, metastatic colorectal cancer, and metastatic non-small cell lung cancer that carry specific BRAF gene mutations, usually in combination with other medicines. Braftovi is taken as a once-daily capsule and works by blocking abnormal proteins made by the mutated BRAF gene to help slow or stop cancer growth.

What is Braftovi Capsule

Braftovi is a brand-name capsule medicine used to treat certain cancers. It contains the active ingredient encorafenib and belongs to a group of medicines called BRAF inhibitors, which are a type of targeted cancer therapy rather than traditional chemotherapy.

Braftovi Capsule uses

• Melanoma (a type of skin cancer) that has spread or cannot be removed by surgery, taken with binimetinib (Mektovi), in people whose cancer has a BRAF V600E or V600K mutation
• Metastatic colorectal cancer with a BRAF V600E mutation, taken with cetuximab (Erbitux) alone or with cetuximab and chemotherapy
• Metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, taken with binimetinib (Mektovi)

Benefits of Braftovi Capsule

• Works in a targeted way against cancer cells that have a specific BRAF gene change, which can help slow or stop cancer growth
• Can be taken with or without food, making dosing more convenient
• Available as a capsule that is swallowed rather than requiring an infusion

How Braftovi Capsule works

Braftovi blocks an abnormal protein made by a mutated BRAF gene that causes cancer cells to grow and multiply quickly. By blocking this protein and other related proteins, Braftovi helps kill cancer cells, shrink tumors, and stop the cancer from growing and spreading. It is usually combined with another targeted medicine that blocks different proteins, which works better than using either medicine alone.

Braftovi Capsule dosage

Take Braftovi once a day, around the same time each day, to help keep a steady level of the medicine in your body. It can be taken with or without food. Swallow the capsules whole with a full glass of water; the capsules are not meant to be crushed, split, or chewed. If you cannot swallow capsules whole, they may be opened and mixed into a small amount of apple sauce and taken right away, discarding any mixture not used within 30 minutes.

If you miss a dose and it is more than 12 hours until your next dose, take the missed dose as soon as possible; if it's less than 12 hours until your next dose, skip the missed dose and continue your regular schedule. Never take two doses together or extra doses to make up for a missed one. If you vomit after taking a dose, do not take an extra dose—just continue with your normal schedule.

Avoid grapefruit and grapefruit juice while taking this medicine. Braftovi is usually taken long-term if it is working well and causing manageable side effects. It is not approved for use in children.

Available forms and strengths

• Oral capsule (75 mg)

Side effects of Braftovi Capsule

Common

• Fatigue/tiredness
• Nausea and vomiting
• Stomach (abdominal) pain
• Joint or muscle pain
• Rash or itching
• Dry skin
• Hair loss
• Constipation or diarrhea
• Reduced appetite
• Headache
• Dizziness
• Numbness, tingling, burning, or pain in hands or feet
• Fever
• Changes in blood test results such as lower red or white blood cell counts, or higher liver enzymes

Serious

• Heart problems, including heart failure or abnormal heart rhythm (QT prolongation)
• Liver damage
• New cancers, including skin cancers such as squamous cell carcinoma or basal cell carcinoma, and other types of cancer
• Serious bleeding, including in the stomach, intestines, or brain
• Eye problems, such as uveitis or other vision changes
• Severe allergic reactions, including swelling of the face, lips, tongue, or throat, and trouble breathing
• Muscle problems (rhabdomyolysis) with weakness, muscle pain, or dark reddish urine
• Blood clots, including in the legs or lungs
• Tumor lysis syndrome, a group of complications from rapid breakdown of cancer cells that can be life-threatening

Warnings and precautions

• Braftovi may cause new skin cancers or other cancers. Your doctor will check your skin regularly before, during, and for a period after treatment, and you should report any new moles, sores, or bumps that bleed or don't heal.
• Braftovi can cause serious bleeding, including in the stomach, intestines, or brain, which can be life-threatening. Seek medical help right away for signs like black or bloody stools, coughing up blood, or sudden severe headache.
• Braftovi can cause changes in heart rhythm (QT prolongation), which can be life-threatening, especially in people with existing heart rhythm problems or those taking other medicines that affect heart rhythm.
• Braftovi can cause serious eye problems such as uveitis. Regular eye exams are recommended, and you should report any eye pain, redness, or vision changes right away.
• Braftovi should not be used in cancers that do not have a BRAF mutation, as it may actually cause cancer cells to grow faster in that situation.
• If Braftovi is taken without its partner medicine (such as during a temporary pause of Mektovi), some side effects like rash may be worse, so your doctor may adjust your dose.
• Braftovi can harm an unborn baby and should not be used during pregnancy. People who can become pregnant should use effective non-hormonal birth control during treatment and for two weeks after stopping, because Braftovi can make hormonal birth control less effective.
• It is not known if Braftovi passes into breast milk or is safe during breastfeeding. It is recommended not to breastfeed during treatment and for two weeks after the last dose.
• Tell your doctor if you have kidney problems before starting Braftovi, as this medicine can affect kidney function and your doctor may need to monitor you or adjust your dose.
• Braftovi can cause liver problems, so your doctor will check your liver function with blood tests before and during treatment. Tell your doctor about any history of liver disease.
• Alcohol isn't known to directly interact with Braftovi, but drinking it may make some side effects, such as nausea, diarrhea, headache, and liver problems, worse. It's a good idea to limit alcohol and ask your doctor if you have concerns.
• Braftovi can affect your ability to drive or use machines, so be careful until you know how the medicine affects you, especially if you have vision changes or other side effects.

Storage

• Store Braftovi in the original pack or bottle until it is time to take the capsules
• Keep the container tightly closed with the desiccant (drying packet) inside; do not remove it
• Store at room temperature, below 25°C (77°F), in a cool, dry place away from moisture, heat, or sunlight
• Do not store in the bathroom, near a sink, in the car, or on windowsills
• Keep out of reach of children and pets
• Do not use if the safety seal under the cap is broken or missing
• If you no longer need the medicine or it is expired, take it to a pharmacy for safe disposal; do not use after the expiry date

When to see a doctor

• Get medical help right away if you have signs of a heart problem, such as a pounding or racing heartbeat, shortness of breath, swelling in your hands, ankles, legs, or feet, or feeling faint or lightheaded.
• Call your doctor right away if you notice yellowing of your skin or eyes, dark or tea-colored urine, nausea, vomiting, loss of appetite, unusual tiredness, bruising, or bleeding, as these can be signs of liver problems.
• Seek urgent medical care for signs of serious bleeding, such as coughing up blood, vomit that looks like coffee grounds, black or tarry stools, nosebleeds, headaches, dizziness, or feeling weak.
• Get medical help right away for symptoms of a blood clot, such as chest pain, sudden shortness of breath, leg pain or swelling, or a cool, pale arm or leg.
• Tell your doctor right away about any new or worsening eye symptoms, such as blurred vision, vision loss, seeing colored dots or halos, or eye pain, swelling, or redness.
• Contact your doctor right away if you feel faint, lightheaded, dizzy, or notice an irregular or fast heartbeat, which may signal a dangerous change in heart rhythm.
• Seek emergency care if you have symptoms of a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, or trouble breathing.
• Tell your doctor immediately about any new skin changes, such as a new wart, a sore or reddish bump that bleeds or doesn't heal, or a change in the size or color of a mole.
• Seek medical attention urgently if you develop symptoms that could indicate tumor lysis syndrome, including nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, reduced urine output, or tiredness.
• If you think you've taken too much Braftovi, contact your doctor or poison control, or go to the emergency room right away, even if you feel fine.

Alternatives

• Zelboraf
• Tafinlar
• Mektovi